Neck Liposuction for the Treatment of Obstructive Sleep Apnea

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Dennis West, Northwestern University
ClinicalTrials.gov Identifier:
NCT01117974
First received: March 19, 2010
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

Liposuction, one of the most common cosmetic procedures performed in the United States, is a surgical technique used to reduce localized areas of excess subcutaneous fat. The neck is a common area of treatment, where liposuction reduces fat volume and neck size. We hypothesize that suctioned removal of fat of the neck will reduce the severity of obstructive sleep apnea.


Condition Intervention
Obstructive Sleep Apnea
Procedure: liposuction of the neck

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neck Liposuction With Tumescent Anesthesia for the Treatment of Obstructive Sleep Apnea - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Apnea-hypopnea index [ Time Frame: Baseline (0 weeks) ] [ Designated as safety issue: No ]
  • Change in the apnea-hypopnea index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep-related quality of life [ Time Frame: Baseline (Week 0) ] [ Designated as safety issue: No ]
  • Change in sleep-related quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liposuction Procedure: liposuction of the neck
Liposuction will be performed to the surgical endpoint (skin thickness in the suctioned areas similar to that of surrounding non-treated skin).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-60 years of age
  • Subjects must have documented mild to moderate obstructive sleep apnea(OSA) syndrome within the last year from the Northwestern University Sleep Clinic
  • Subjects must qualify as "very sleepy" on the Epworth Sleepiness Scale
  • Females must have neck circumference of 16.0 cm or greater, and males must have neck circumference of 17.0 cm or greater
  • Subjects must be a good candidates for neck liposuction as determined by the study physician
  • Subjects must be in good health and is able to undergo the liposuction procedure

Exclusion Criteria:

  • Pregnant or lactating female
  • Subjects who are unable to understand the protocol or to give informed consent
  • Subjects dependent on blood thinners
  • Subjects with bleeding diathesis
  • Subjects with a history of poor wound healing, skin fragility, poor skin elasticity, or hypertrophic or keloidal scarring
  • Subjects with a history of excessive surgeries on the neck in the area to be treated
  • Subjects who are allergic to lidocaine or who have previously had an adverse reaction to epinephrine
  • Subjects with non-apnea sleep disorders such as restless leg syndrome, insomnia, circadian rhythm disorders
  • Subjects with chronic obstructive pulmonary disease
  • Subjects with craniofacial abnormalities
  • Subjects with hypoventilation
  • Subjects with large tonsils/adenoids or an abnormal airway exam as determined by the study physician
  • Subjects with an anatomical nasal obstruction
  • Subjects who have a large tongue
  • Subjects with severe cardiopulmonary risks as determined by the study physician
  • Subjects who cannot complete an MRI
  • Subjects who intend to pursue other treatments for OSA during the duration of this study
  • Any previous and/or pending procedures at the treatment area or that may likely affect the treatment area
  • Pending and/or anticipated major change in diet or exercise pattern in the six weeks following the last treatment
  • Subjects with a Body Mass Index >35kg/m2
  • Subjects treated with continuous positive airway pressure (CPAP) within one month of study enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117974

Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Simon Yoo, MD Northwestern University
Principal Investigator: Dennis P West, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Dennis West, Associate Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT01117974     History of Changes
Other Study ID Numbers: STU17637
Study First Received: March 19, 2010
Last Updated: April 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014